# K140625: Orthosorb LS

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 18, 2014 after 38 days
- Product code: OVZ (Pin, Fixation, Resorbable, Hard Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K901456 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901456: Orthosorb (R) Absorbable Pin, Johnson & Johnson International (1990) Summary page 1.
- K111077: Orthosorb Resorbable Pins, DePuy Orthopaedics, Inc. (2011) Summary page 1.
- K990291: Lactosorb Bone Pin, Biomet, Inc. (1999) Summary page 1.

## Indications for use
1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals; 2.) For fixation of inherently stable osteatomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities. 3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.

Source page: https://510kreport.com/device/K140625
Methodology: https://510kreport.com/methodology